Journal of cancer research and therapeutics · 2016
Can pure accelerated radiotherapy given as six fractions weekly be an option in locally advanced carcinoma cervix: Results of a prospective randomized phase III trial.
Клиническое исследование III фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Sharma Mukesh, Revannasiddaiah Swaroop, Gupta Manish, Seam Rajeev K, Gupta Manoj K, Rastogi Madhup
Аннотация
CONTEXT: Concurrent chemoradiation is presently the standard of care in locally advanced malignancy of the cervix uteri. But accelerated radiotherapy regimes have not been investigated much.
AIMS: We conducted a randomized trial to compare the results of pure accelerated radiotherapy given as six fractions weekly to standard chemoradiotherapy in locally advanced carcinoma cervix patients.
SETTINGS AND DESIGN: This was a prospective, phase III trial in which 106 patients of locally advanced (stage II and III) carcinoma cervix were randomized into two arms.
SUBJECTS AND METHODS: The study arm (ART) received 50 Gy accelerated radiotherapy in 25 fractions, six fractions weekly; while control (CRT) arm was treated with concurrent chemoradiation 50 Gy in 25 fractions with weekly injection cisplatin. This was followed by intracavitary brachytherapy (ICBT; total dose of 85 Gy to point A) in both the arms. Fifty-one patients completed treatment in the ART arm and 50 patients in the CRT arm. In these patients, response to treatment, toxicity, and overall survival (OS) and disease-free survival (DFS) were compared between both the arms.
STATISTICAL ANALYSIS USED: Survival analysis was done using Kaplan.Meier estimates, logrank test was used to compare differences, while proportions were compared using the Fisher's t-test.
RESULTS: At a median follow.up of 36. months there was no difference between the two arms in terms of OS. (61 vs 62%,P = 0.9009) as well as DFS. (60 vs 64%,P = 0.6411) CONCLUSIONS: Accelerated radiotherapy given as six fractions per week is an effective alternative to concomitant chemoradiation in locally advanced carcinoma cervix and has shown lesser toxicities in our study.
AIMS: We conducted a randomized trial to compare the results of pure accelerated radiotherapy given as six fractions weekly to standard chemoradiotherapy in locally advanced carcinoma cervix patients.
SETTINGS AND DESIGN: This was a prospective, phase III trial in which 106 patients of locally advanced (stage II and III) carcinoma cervix were randomized into two arms.
SUBJECTS AND METHODS: The study arm (ART) received 50 Gy accelerated radiotherapy in 25 fractions, six fractions weekly; while control (CRT) arm was treated with concurrent chemoradiation 50 Gy in 25 fractions with weekly injection cisplatin. This was followed by intracavitary brachytherapy (ICBT; total dose of 85 Gy to point A) in both the arms. Fifty-one patients completed treatment in the ART arm and 50 patients in the CRT arm. In these patients, response to treatment, toxicity, and overall survival (OS) and disease-free survival (DFS) were compared between both the arms.
STATISTICAL ANALYSIS USED: Survival analysis was done using Kaplan.Meier estimates, logrank test was used to compare differences, while proportions were compared using the Fisher's t-test.
RESULTS: At a median follow.up of 36. months there was no difference between the two arms in terms of OS. (61 vs 62%,P = 0.9009) as well as DFS. (60 vs 64%,P = 0.6411) CONCLUSIONS: Accelerated radiotherapy given as six fractions per week is an effective alternative to concomitant chemoradiation in locally advanced carcinoma cervix and has shown lesser toxicities in our study.